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Sponsors and Collaborators: |
SK Life Science The Epilepsy Study Consortium |
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Information provided by: | SK Life Science |
ClinicalTrials.gov Identifier: | NCT00616148 |
The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy patients, and to measure the onset and duration of the effect. Several cohorts will be used, to sequentially investigate different doses.
Condition | Intervention | Phase |
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Epilepsy |
Drug: YKP3089 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Single Group Assignment |
Official Title: | Pharmacodynamic Evaluation of YKP3089 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG-Response: Proof of Principle |
Estimated Enrollment: | 12 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 1 and Cohort 2: Placebo Comparator |
Drug: YKP3089
Oral dosage form
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Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Ann Brodie | 212-263-8495 | mbrodie.nyumc@gmail.com |
Contact: Bree Vogelsong | 212-263-8495 | vogelsong.nyuumc@gmail.com |
United States, Maryland | |
Johns Hopkins Medical Center | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Gregory Krauss, M.D. | |
Principal Investigator: Gregory Krauss, M.D. | |
United States, New York | |
Montefiore Medical Center | Recruiting |
Bronx,, New York, United States, 10467 | |
Contact: Alex Boro, M.D. | |
Principal Investigator: Alex Boro, M.D. | |
Cornell Medical Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Cynthia Hardin, M.D. | |
Principal Investigator: Cynthia Hardin, M.D. | |
United States, Pennsylvania | |
University of Pennsylvania Epilepsy Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: John Pollard, M.D. | |
Principal Investigator: John Pollard, M.D. |
Principal Investigator: | Jacqueline French, M.D. | NYU MEDICAL CENTER |
Responsible Party: | SK Life Science, Inc. ( S. James Lee, Ph.D., VP Development and Regulatory ) |
Study ID Numbers: | AA40616 |
Study First Received: | February 4, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00616148 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Epilepsy Seizures |
Epilepsy, Reflex Epilepsy Seizures |
Central Nervous System Diseases Photosensitive Epilepsy Brain Diseases |
Epilepsy, Reflex Epilepsy Nervous System Diseases Central Nervous System Diseases Brain Diseases |